A limited, but significant, incorporation of cytarabine into both DNA and RNA has also been reported. Cytarabine Injection is contraindicated in those patients who are hypersensitive to the drug. Each mL contains 100 mg Cytarabine USP, in 2 g per 20 mL (100 mg per mL) single dose vial and the following inactive ingredients: water for injection q.s. The dosage schedule is usually governed by the type and severity of central nervous system manifestations and the response to previous therapy. This is followed by a brief rise which peaks around the twelfth day. It exhibits cell phase specificity, Cytarabine Injection is available as follows: For Intravenous, Intrathecal and Subcutaneous Use Only. Rarely, severe skin rash, leading to desquamation has been reported. A syndrome of sudden respiratory distress, rapidly progressing to pulmonary edema and radiographically pronounced cardiomegaly has been reported following experimental high dose therapy with cytarabine used for the treatment of relapsed leukemia from one institution in 16/72 patients. There is a definite, but considerably reduced risk if therapy is initiated during the second or third trimester. Immunosuppressive Action: Cytarabine is capable of obliterating immune responses in man during administration with little or no accompanying toxicity. If a precipitate has formed as a result of exposure to low temperatures, redissolve by warming up to 55C for no longer than 30 minutes, under dry heat conditions, and shake until the precipitate has dissolved. Procedures for proper handling and disposal of anti-cancer drugs should be considered. RxNorm, Patients receiving this drug must be under close medical supervision and, during induction therapy, should have leukocyte and platelet counts performed daily. Extensive chromosomal damage, including chromatoid breaks, have been produced by Cytarabine and malignant transformation of rodent cells in culture has been reported. Events, (What Using your dominant hand, insert the needle quickly at a 90 angle. 5. Cytarabine Injection can cause fetal harm when administered to a pregnant woman. Patients receiving Cytarabine must be monitored closely. There is an initial distributive phase with a half-life of about 10 minutes, followed by a second elimination phase with a half-life of about 1 to 3 hours. After the distributive phase, more than 80 percent of plasma radioactivity can be accounted for by the inactive metabolite 1--D-arabinofuranosyluracil (ara-U). Additional medications in the Prescription Medications section by. Cases of cardiomyopathy with subsequent death have been reported following experimental high dose therapy with Cytarabine in combination with cyclophosphamide when used for bone marrow transplant preparation. This cardiac toxicity may be schedule dependent. Regardless of initial count, dosage level, or schedule, there is an initial fall starting the first 24 hours with a nadir at days 79. Both of these cases had first trimester exposure. Palo Alto, CA; Jazz Pharmaceuticals, Inc., March 2021. Facilities should be available for management of complications, possibly fatal, of bone marrow suppression (infection resulting from granulocytopenia and other impaired body defenses, and hemorrhage secondary to thrombocytopenia). This study suggests that in patients on cytarabine being treated with gentamicin for a K. pneumoniae infection, the lack of a prompt therapeutic response may indicate the need for re-evaluation of antibacterial therapy. ), More about getting RSS News & Updates from DailyMed, 5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product, ANALYSIS(61703-305) , MANUFACTURE(61703-305) , PACK(61703-305) , LABEL(61703-305), 20 Deoxycytidine prevents or delays (but does not reverse) the cytotoxic activity. For Intravenous, Intrathecal and Subcutaneous Use Only. There is no antidote for overdosage of Cytarabine Injection. Patients treated with high-dose cytarabine should be observed for neuropathy since dose schedule alterations may be needed to avoid irreversible neurologic disorders. To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information: *If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site. CYTARABINE- cytarabine injection, solutionHospira, Inc. NOT FOR INTRATHECAL USE CONTAINS BENZYL ALCOHOL FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY. Parenteral drugs should be inspected visually for particulate matter and discoloration, prior to administration, whenever solution and container permit. Because cerebrospinal fluid levels of deaminase are low, little conversion to ara-U was observed. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No. Two patients with adult acute non-lymphocytic leukemia developed peripheral motor and sensory neuropathies after consolidation with high-dose Cytarabine, daunorubicin, and asparaginase. Following 5-day courses of intensive therapy with Cytarabine the immune response was suppressed, as indicated by the following parameters: macrophage ingress into skin windows; circulating antibody response following primary antigenic stimulation; lymphocyte blastogenesis with phytohemagglutinin. This study suggests that in patients on Cytarabine being treated with gentamicin for a K. pneumoniae infection, the lack of a prompt therapeutic response may indicate the need for re-evaluation of antibacterial therapy. Cases of cardiomyopathy with subsequent death have been reported following experimental high dose therapy with cytarabine in combination with cyclophosphamide when used for bone marrow transplant preparation. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia. Reversible decreases in steady-state plasma digoxin concentrations and renal glycoside excretion were observed in patients receiving beta-acetyldigoxin and chemotherapy regimens containing cyclophosphamide, vincristine and prednisone with or without Cytarabine Injection or procarbazine. Severe and at times fatal CNS, GI and pulmonary toxicity (different from that seen with conventional therapy regimens of cytarabine) has been reported following some experimental dose schedules for cytarabine. WARNING Subcutaneous Use Only, Cytarabine Injection The most frequently used dose was 30 mg/m2 every 4 days until cerebrospinal fluid findings were normal, followed by one additional treatment. Women of childbearing potential should be advised to avoid becoming pregnant. https://medlibrary.org/lib/rx/meds/cytarabine/. This may be due to potential competitive inhibition of its uptake. Cytarabine given intrathecally may cause systemic toxicity and careful monitoring of the hemopoietic system is indicated. Therapeutic abortions were done in five cases. Cytarabine Injection is contraindicated in those patients who are hypersensitive to the drug. Single Dose Onco-Tain Glass Fliptop Vial . Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. The outcome of this syndrome can be fatal. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium) for cytarabine/daunorubicin liposome. After the needle is inserted, release the skin with your nondominant hand. One apparently normal infant died at 90 days of gastroenteritis. A few days after termination of therapy there was a rapid return to normal. Rarely, severe skin rash, leading to desquamation has been reported. These CBD candies offer a simple and flexible . Controlling Occupational Exposure to Hazardous Drugs. Periodic checks of bone marrow, liver and kidney functions should be performed in patients receiving Cytarabine Injection. Clinical evidence in one patient showed possible inhibition of fluorocytosine efficacy during therapy with Cytarabine. Cytarabine is a potent bone marrow suppressant. 2. This third-party website is neither owned nor controlled by Pfizer, and Pfizer does not endorse and is not responsible for the content or services of this site. Single doses as high as 3 g/m2 have been administered by rapid intravenous infusion without apparent toxicity. Cytarabine is a potent bone marrow suppressant. Copy the URL below and paste it into your RSS Reader application. National Comprehensive Cancer Network, 2022. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Available for Android and iOS devices. Therefore, Cytarabine should not be administered immediately before or after a dialysis. DESCRIPTION Cytarabine Injection, an antineoplastic, is a sterile solution of cytarabine for intravenous and subcutaneous use which contains no preservative and is available in 20 mg/mL (1000 mg/50 mL) Pharmacy Bulk Package. Facilities should be available for management of complications, possibly fatal, of bone marrow suppression (infection resulting from granulocytopenia and other impaired body defenses, and hemorrhage secondary to thrombocytopenia). Cytarabine has been used intrathecally in newly diagnosed children with acute lymphocytic leukemia as well as in the treatment of meningeal leukemia. Therapy should be started cautiously in patients with pre-existing drug-induced bone marrow suppression. Counts of formed elements in the peripheral blood may continue to fall after the drug is stopped and reach lowest values after drug-free intervals of 12 to 24 days. Although normal infants have been delivered to patients treated in all three trimesters of pregnancy, follow-up of such infants would be advisable. Cerebrospinal fluid levels of cytarabine are low in comparison to plasma levels after single intravenous injection. Prior clinical studies demonstrated a sustained drug ratio and exposure in vivo and prolonged survival versus standard-of-care cytarabine plus daunorubicin chemotherapy (7+3 regimen) in older . Physician Prescribing Information CYTARABINE, 500 mg/25 mL Multi-Dose Vial U.S. The structural formula is: Cytarabine is an odorless, white to off-white crystalline powder which is freely soluble in water and slightly soluble in alcohol and in chloroform. However, it had no effect on already established delayed hypersensitivity reactions. Platelet depression is noticeable at 5 days with a peak depression occurring between days 12 to 15. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. [See USP Controlled Room Temperature.] Requests for samples of prescription medications can be made by contacting Pfizer for Professionals at 1-800-505-4426 or by visiting the PfizerPro website www.pfizerpro.com. One case of anaphylaxis that resulted in acute cardiopulmonary arrest and required resuscitation has been reported. View Labeling Archives, The severity of these reactions are dose and schedule dependent. Cytarabine is a potent bone marrow suppressant. Extensive chromosomal damage, including chromatoid breaks have been produced by cytarabine and malignant transformation of rodent cells in culture has been reported. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. However, it had no effect on already established delayed hypersensitivity reactions. Frequent platelet and leucocyte counts and bone marrow examinations are mandatory. The most frequently reported reactions after intrathecal administration were nausea, vomiting and fever; these reactions are mild and . Before making this judgement or beginning treatment, the physician should be familiar with the following text. Cytarabine causes abnormal cerebellar development in the neonatal hamster and is teratogenic to the rat fetus. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. Med J Australia, 1983; 1:426-428. Because of the potential for abnormalities with cytotoxic therapy, particularly during the first trimester, a patient who is or who may become pregnant while on cytarabine should be apprised of the potential risk to the fetus and the advisability of pregnancy continuation. Facilities should be available for management of complications, possibly fatal, of bone marrow suppression (infection resulting from granulocytopenia and other impaired body defenses and hemorrhage secondary to thrombocytopenia). However, it had no effect on already established delayed hypersensitivity reactions. If the symptoms of the syndrome are deemed treatable, corticosteroids should be contemplated as well as continuation of therapy with Cytarabine. Following rapid intravenous injection of cytarabine labeled with tritium, the disappearance from plasma is biphasic. Cases of cardiomyopathy with subsequent death has been reported following experimental high dose therapy with cytarabine in combination with cyclophosphamide when used for bone marrow transplant preparation. The outcome of this syndrome can be fatal. Two cases of pancreatitis have been reported following experimental doses of Cytarabine and numerous other drugs. nwDFeXAB4`16 !OdB&B`CC`lq~ODo)aSnuzSW (current). When necessary the pH is adjusted with hydrochloric acid and/or sodium hydroxide to a pH of 7.7. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration and hepatic dysfunction. The product information provided by this site is intended only for health care professionals, patients, consumers and caregivers in the United States. The container closure is not made with natural rubber latex. Npoje s vysokm obsahom antioxidantov, ako s vitamny C a E, preukzatene zlepuj erektiln funkciu tm, e brnia pokodeniu buniek, produkujcich oxid dusnat," hovor Pearlmanov. Cytarabine also suppressed the development of cell-mediated responses such as delayed hypersensitivity skin reaction to dinitrochlorobenzene. Doses of 4.5 g/m2 by intravenous infusion over 1 hour every 12 hours for 12 doses have caused an unacceptable increase in irreversible CNS toxicity and death. Safety Data Sheet. Therefore, monitoring of plasma digoxin levels may be indicated in patients receiving similar combination chemotherapy regimens. The literature should be consulted for the current recommendations for use in acute lymphocytic leukemia. In order to provide you with relevant and meaningful content we need to know more about you. Within 24 hours about 80 percent of the administered radioactivity can be recovered in the urine, approximately 90 percent of which is excreted as 1--D-arabinofuranosyluracil. Following 5-day constant infusions or acute injections of 50 mg/m2 to 600 mg/m2, white cell depression follows a biphasic course. Before making this judgment or beginning treatment, the physician should be familiar with the following text. When large intravenous doses are given too quickly, patients are frequently nauseated and may vomit for several hours post-injection. The NCCN Compendium is a derivative work of the NCCN Guidelines. DESCRIPTION Cytarabine for Injection, USP, commonly known as ara-C, an antineoplastic, is a sterile lyophilized materialfor reconstitution and intravenous, intrathecal or subcutaneous administration. DO NOT USE CYTARABINE INJECTION (which contains benzyl alcohol) INTRATHECALLY. We comply with the HONcode standard for trustworthy health information. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, For Intravenous, Intrathecal and To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or. Viral, bacterial, fungal, parasitic, or saprophytic infections, in any location in the body may be associated with the use of Cytarabine alone or in combination with other immunosuppressive agents following immunosuppressant doses that affect cellular or humoral immunity. If experimental high dose therapy is used, do not use a Cytarabine Injection containing benzyl alcohol. Cerebrospinal fluid levels of Cytarabine are low in comparison to plasma levels after single intravenous injection. Facilities should be available for management of complications, possibly fatal, of bone marrow suppression (infection resulting from granulocytopenia and other impaired body defenses, and hemorrhage secondary to thrombocytopenia). However, in one patient in whom cerebrospinal fluid levels are examined after 2 hours of constant intravenous infusion, levels approached 40 percent of the steady state plasma level. Files, Presentations Rarely, severe skin rash, leading to desquamation has been reported. Single Dose Vials, Boxed Warnings, After the distributive phase, more than 80 percent of plasma radioactivity can be accounted for by the inactive metabolite 1--D-arabinofuranosyluracil (ara-U). If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985. Napumpujte ho antioxidantmi a vitamnmi! Cytarabine Injection is capable of obliterating immune responses in man during administration with little or no accompanying toxicity. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Cases of cardiomyopathy with subsequent death have been reported following experimental high dose therapy with Cytarabine in combination with cyclophosphamide when used for bone marrow transplant preparation. Severe and at times fatal CNS, GI and pulmonary toxicity (different from that seen with conventional therapy regimens of Cytarabine Injection) has been reported following some experimental dose schedules for Cytarabine Injection. Cytarabine is cytotoxic to a wide variety of proliferating mammalian cells in culture. Suppression of antibody responses to E. coli-VI antigen and tetanus toxoid have been demonstrated. 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